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510(k) Data Aggregation

    K Number
    K232502
    Device Name
    Cocoon Convective Warming System, Model CWS7000
    Manufacturer
    Care Essentials Pty Ltd
    Date Cleared
    2024-02-21

    (187 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Care Essentials Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cocoon Convective Warming System, Model CWS7000, is indicated for patient warming. The Cocoon Convective Warming Unit, Model CWS7000 has been designed for use with Cocoon Disposable Patient Warming Gown Blankets. It is intended for use with children, adolescent, and adult patients.
    Device Description
    The Cocoon Convective Warming System, Model CWS7000 is part of the Cocoon family of temperature management systems that consists of portable forced-air temperature management units, Cocoon™ Disposable Patient Warming Gown Blanket. The Cocoon Convective Warming System, Model CWS7000 comprises of the Cocoon Convective Warming Unit, Model CWS7000 unit and the Cocoon™ Disposable Patient Warming Gown Blankets. The Cocoon Convective Warming System, Model CWS7000 can be used in preoperative and postoperative settings. In a preoperative setting, the warming system provides prewarming and comfort warming. In a postoperative setting, the warming system provides comfort warming only. The Cocoon Convective warming system should be used by trained medical professionals only. The Cocoon™ Convective Warming System, Model CWS7000 is not intended for use in the operating room.
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    K Number
    K213907
    Device Name
    CareGUARD Sterilization Wrap
    Manufacturer
    Care Essentials Pty Ltd
    Date Cleared
    2022-03-14

    (90 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Care Essentials Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CareGUARD* Sterilization Wrap is a single-use, non-woven sterilization wrap intended to be sterilized by a health care provider using pre-vacuum steam at 273ºF / 134ºC for 4 minutes. The CareGUARD* Sterilization Wrap was validated for a dry time of 30 minutes. The CareGUARD* Sterilization wrap is recommended to be used with trays weighing up to 13.7 lbs. The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used. Test results validated that CareGUARD* Sterilization wraps allowed sterilization of the enclosed devices by pre-vacuum cycles.
    Device Description
    CareGUARD* Sterilization Wrap is made from 100% polypropylene spunbond-meltblownspunbond (SMS) non-woven fabric. The sterilization wrap is provided in three different material basis weights of three product offerings in various dimensions. CareGUARD* Single Layer Sterilization wrap is comprised of a single sheet or one layer of SMS fabric. CareGUARD* Dual Layers Sterilization Wrap and CareGUARD* Contrast Sterilization Wrap, are comprised of two single layer sheets of SMS fabric ultrasonically bonded along two opposing edges. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSI/AAMI ST79:2017 and allows for a sterilized pack to be opened aseptically. All basis weights utilize the same material technology. This product is a single-use and a non-sterile medical device. CareGUARD* Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using pre-vacuum steam at 273°F/134°C for 4 minutes.
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    K Number
    K181671
    Device Name
    Cocoon Convective Warming System
    Manufacturer
    Care Essentials Pty Ltd
    Date Cleared
    2019-05-02

    (311 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Care Essentials Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cocoon Convective Warming System is indicated for hyper or hypothermic patients for whom induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Cocoon Convective Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm. The Cocoon Convective Warming System can be used with adult and pediatric patients.
    Device Description
    Not Found
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    K Number
    K140635
    Device Name
    COCOON CONVECTIVE WARMING SYSTEM
    Manufacturer
    CARE ESSENTIALS PTY LTD
    Date Cleared
    2014-07-25

    (135 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARE ESSENTIALS PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cocoon Convective Warming System is indicated for hyper or hypothermic patients or normothermic patients for whom induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Cocoon Convective Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm. The Cocoon Convective Warming System can be used with adult and pediatric patients.
    Device Description
    The Cocoon Convective Warming system incorporates the Convective Warming Machine CWS4000, and the Cocoon Disposable Patient Warming Blankets. The Convective Warming Machine is a mains-powered, microprocessor-controlled device that delivers a continuous flow of temperature-controlled air through a flexible hose to the warming blanket. The temperature of the air delivered to the blanket can be set to one of six settings: Ambient, 34℃, 37℃, 40℃, 43ºC, or 46ºC. When a temperature of 46ºC is selected, the setting automatically drops to 43ºC after 10 minutes.
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